What are regulations on cancellation of medical devices classification results in Vietnam?

According to Article 6 of Decree 98/2021/ND-CP (Effective from 01/01/2022), the provisions on cancellation of medical devices classification results in Vietnam are as follows:

1. Classification results shall be cancelled in the following cases:

a) The incorrect classification result reduces the level of risk of the medical device;

b) The record of classification results is found fraudulent.

2. Procedures for cancellation:

a) Within 01 working day from the day on which a conclusion mentioned in Clause 1 of this Article is given, the Ministry of Health shall issue a decision to cancel classification result which request the classification body to implement remedial measures (if any) and remove the cancelled classification result from the Portal on management of medical devices.

The decision to cancel classification result shall be sent to the classification body, Provincial Departments of Health, General Department of Customs and border checkpoint customs authorities, and published on the Portal on management of medical devices.

b) After receiving the decision to cancel classification result, the classification body shall cancel all classification results specified in the decision and implement remedial measures against its violations (if any).

c) After receiving the decision to cancel classification result, the authority that has received the application for declaration of applied standards or application for registration number (hereinafter referred to as “application for registration number”) shall review the registration numbers issued, and follow procedures for revoking the registration numbers of medical devices that have been issued using classification results specified in the Ministry of Health’s decision to cancel classification results.

Best Regards!